4. Clinical Efficacy Testing

Linking Mechanism to Clinical Efficacy


Fc profiling connects in vitro activity to real-world immune engagement.


Comprehensive effector function profiling of nirsevimab (ADNP, ADCP, ADCD, ADCC) revealed innate immune activation not captured by neutralization assays alone. Ex vivo analysis of clinical serum samples confirmed that Fc-mediated activity persisted post-dose, tying lab results to patient-level immune response. This mechanistic clarity helped de-risk development and support clinical validation.



  • Demonstrated in vivo relevance of Fc-mediated activity in patient samples
  • Identified complementary immune pathways contributing to efficacy
  • Provided functional evidence to support clinical mechanism-of-action claims